STROMECTOL- ivermectin tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)

Доступна с:

Department of State Health Services, Pharmacy Branch

ИНН (Международная Имя):

IVERMECTIN

состав:

IVERMECTIN 3 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

STROMECTOL is indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract . STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis . This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.) Onchocerciasis . STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus . This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: STROMECTOL has no activity against adult Onchocerca volvulus parasites. The adult parasites resid

Обзор продуктов:

No. 8495 — Tablets STROMECTOL 3 mg are white, round, flat, bevel-edged tablets coded MSD on one side and 32 on the other side. They are supplied as follows: NDC 0006-0032-20 unit dose packages of 20. Store at temperatures below 30°C (86°F). Dist. by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Manufactured by: Merck Sharp & Dohme BV Waarderweg 39 2031 BN Haarlem Netherlands Issued May 2010 Printed in the Netherlands 9032319 87447/080610 8495

Статус Авторизация:

New Drug Application

Характеристики продукта

STROMECTOL- IVERMECTIN TABLET
DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH
----------
STROMECTOL®
(IVERMECTIN)
TABLETS
DESCRIPTION
STROMECTOL
(Ivermectin) is a semisynthetic, anthelmintic agent for oral
administration. Ivermectin
is derived from the avermectins, a class of highly active
broad-spectrum, anti-parasitic agents isolated
from the fermentation products of _Streptomyces avermitilis_.
Ivermectin is a mixture containing at least
90% 5- _O_-demethyl-22,23-dihydroavermectin A
and less than 10% 5- _O_-demethyl-25-de(1-
methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A
, generally referred to as 22,23-
dihydroavermectin B
and B
, or H
B
and H
B
, respectively. The respective empirical
formulas are C
H
O
and C
H
O
, with molecular weights of 875.10 and 861.07,
respectively. The structural formulas are:
Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline
powder with a melting point of
about 155°C. It is insoluble in water but is freely soluble in
methanol and soluble in 95% ethanol.
STROMECTOL is available in 3-mg tablets containing the following
inactive ingredients:
microcrystalline cellulose, pregelatinized starch, magnesium stearate,
butylated hydroxyanisole, and
citric acid powder (anhydrous).
1
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Following oral administration of ivermectin, plasma concentrations are
approximately proportional to
the dose. In two studies, after single 12-mg doses of STROMECTOL in
fasting healthy volunteers
1
1a
1a
1a
1b
2
1a
2
1b
48
74
14
47
72
14
Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc.Copyright © 1996,
2007 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All
rights reserved
(representing a mean dose of 165 mcg/kg), the mean peak plasma
concentrations of the major component
(H
B
) were 46.6 (±21.9) (range: 16.4-101.1) and 30.6 (±15.6) (range:
13.9-68.4) ng/mL,
respectively, at approximately 4 hours after dosing. Ivermectin is
metabolized in the liver, and
ivermectin and/or its metabolites ar